Comparison of Tramadol, Pethidine and Morphine in the Treatment of Pain After Thoracic Surgery

Analgesia Clinical Trial

Official title:

Comparison of the Analgesic Effects of Tramadol, Pethidine and Morphine Under Erector Spinae Plane (ESP) Block in the Treatment of Pain After Elective Thoracic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06172920
• Other study ID #: KA23/137
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 31, 2023
• Est. completion date: December 9, 2024

Study information

• Verified date: December 2023
• Source: Baskent University
• Contact: Begum N Gokdemir, MD
• Phone: 03122036868
• Email: begokdemir[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of analgesic effects of tramadol, aldolan and morphine under thoracic surgery

Description:

Thoracotomy is one of the most painful surgical procedures known, and severe pain is encountered in 21-67% of patients after thoracotomy. The most important causes of this pain arise from the bone structures of the thoracic wall, damage to the costal joint junctions, stretching of the ligaments, rib fractures, and damage to the intercostal nerve and major muscles. Another factor that causes pain after thoracotomy is the chest tubes placed in the thorax to provide drainage (1).

As a result of this pain caused by loss of tissue and pulmonary reserve, effective coughing and decreased chest expansion can lead to serious complications such as atelectasis, ventilation/perfusion mismatch, hypoxemia, immobilization, thromboembolism and infection. These complications are associated with increased morbidity and mortality in thoracic surgery (2).

Ensuring pain management in patients undergoing thoracotomy is important in terms of reducing postoperative complications, ensuring early mobilization and increasing patient comfort. Since there is no single source that causes pain after thoracotomy, pain must be controlled at all levels. For this reason, a multimodal approach using pharmacological and non-pharmacological techniques is preferred in analgesia after thoracotomy. This approach reduces drug side effects along with the consumption of analgesics. Opioids and nonsteroidal anti-inflammatory drugs are used in pharmacological analgesia.

In our study, the investigators aim to compare the effects of tramadol, pethidine and morphine using intravenous patient-controlled analgesia in the treatment of postoperative pain in elective thoracic surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 9, 2024
• Est. primary completion date: November 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Having non-urgent thoracic surgery

• over 18 years old

• Being in group I-III according to the American Society of Anesthesiologists (ASA) classification

• Not have allergies to the drugs to be used (volunteers with diseases that prevent the use of drugs will not be included in the study

• regardless of gender

Exclusion Criteria:

. Have allergies to the drugs to be used

Related Conditions & MeSH terms

• Analgesia
• Thoracic Diseases

Intervention

Drug:
• Tramadol hydrochloride
Patients are receiving tramadol hydrochloride under thoracic surgery
• Aldolan
Patients are receiving meperidine under thoracic surgery
• Morphine hydrochloride
Patients are receiving Morphine hydrochloride under thoracic surgery

Locations

Country	Name	City	State
Turkey	Baskent University Ankara Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of drugs's analgesic effects	To compare the analgesic effects of tramadol, pethidine and morphine in the treatment of postoperative pain in thoracic surgery, It will be assesed with numeric rating scale ( 0= no pain, 10= worst pain imaginable)	postoperative 24 hours
Primary	Comparing hemodynamic effects	To compare hemodynamic effects of tramadol, pethidine and morphine in the treatment of postoperative pain in thoracic surgery, It will be asssesed with measurements of intraoperative values of systolic, diastolic and mean arterial blood pressure	Intraoperatively, then postoperative 24 hours
Primary	Comparing respiratory effects	To compare respiratory effects of tramadol, pethidine and morphine in the treatment of postoperative pain in thoracic surgery. It will be asssesed with postoperative pulmonary complications such as failed extubation, bronchospasms or respiratory depressions.	postoperative 24 hours
Secondary	Adverse effects of analgesics	It was aimed to compare the effects of drugs in terms of side effects, early mobilization.	postoperative 24 hours
Secondary	surgeon satisfaction	With a questionnaire, surgeon satisfaction will be assessed. (0 point= strongly disagree, 5 point= strongly agree)	Immediately after the surgery
Secondary	patient satisfaction	With a questionnaire, patient satisfaction will be assessed. (0 point= strongly disagree, 5 point= strongly agree) When Aldrete score> 8, patient will be questioned for satisfaction.	Postoperative 30th minute